Lunit has officially launched its Lunit INSIGHT CXR4, an advanced AI chest X-ray analysis tool, which has received CE certification under the Medical Device Regulation (MDR).
Designed to aid radiologists, the system utilises artificial intelligence (AI) to detect a wide array of thoracic conditions, such as lung nodules, pneumonia, and pneumothorax. It also includes capabilities for identifying acute bone fractures, aiming to improve diagnostic precision and enable early detection of critical diseases.
The updated Lunit INSIGHT CXR4 offers several enhancements intended to streamline clinical workflows.
Its Normal Flagging feature uses an AI engine trained on over 1.2 million chest X-rays to accurately identify normal cases with a high negative predictive value of 99.5%. This helps in generating automatic reports for low-risk cases, reducing the time radiologists spend on routine examinations.
Another new feature, Current-Prior Comparison, assesses changes over time by comparing a patient’s current and previous X-ray images. This functionality is particularly beneficial for tracking disease progression or improvement and supports nodule comparisons crucial for lung cancer monitoring.
In addition, the system now includes the ability to detect acute bone fractures within the field of view of chest X-rays. This capability assists in identifying minor fractures that might otherwise be overlooked, ultimately reducing interpretation times and enhancing diagnostic accuracy.
The CE MDR certification positions Lunit to deploy its enhanced solution across Europe, targeting the management of high imaging volumes with greater diagnostic confidence and efficiency.
The company plans to seek further regulatory approvals to expand the availability of CXR4 into additional regions. Lunit is focused on integrating its AI solutions into diverse healthcare systems’ clinical workflows.
Lunit CEO Brandon Suh said: “With Lunit INSIGHT CXR4, we’ve gone beyond expanding detection—we’ve focused on what truly helps clinicians in their day-to-day workflow.
“Features like active normal flagging and current-prior comparison are designed to reduce reading time and improve triage confidence, especially in high-volume settings. CE MDR certification is a key step toward broader adoption, and we’re committed to bringing CXR4 to more hospitals worldwide.”
